With FDA Approval, a Gout Drug Now Costs $5 Instead of Pennies

By James A. White

The recent history of a medicine used to treat gout provides another chapter in the book of unintended consequences. We’ll recount some highlights of the tale as spelled out in this morning’s WSJ:

A common gout drug, colchicine, has been around for so long that pre-dated the FDA and until last year, it had never been approved by the agency. As part of a push by the FDA to bring such drugs under its umbrella, a company called URL Pharma commissioned studies to show that colchicine was safe and effective, and last summer the FDA approved the company’s version and gave URL three years of marketing exclusivity for the drug.

Here come the unintended consequences. While the FDA says it hoped there wouldn’t be a significant run-up in the price of colchicine — sold as Colcrys by URL — the retail cost has soared to more than $5 a bill from the previous pennies a tablet. URL Pharma also sued five makers of manufacturers of colchicine, saying they have been illegally marketing their colchicine products since Colcrys’s approval. One of those makers has settled the matter and stopped production. The other four companies are fighting the lawsuit.

URL Pharma says it priced Colcrys in line with other approved, branded drugs used to treat gout pain. It’s also trying to help patients who need financial assistance, including providing a three-months’ supply to low-income patients for $15.

Further, URL Pharma says its trials helped make colchicine safer for everyone, noting there wasn’t even a standard dosage for the medicine until the company went through the FDA approval process.

Comments (5 of 33)

"We need to make an impact in early stages, make certain clients being affected by persistent ache usually are addressed while well as possible,Inch Doctor. Herndon said.

8:12 am February 25, 2013

Shelden wrote :

Wow, incredible weblog format! How long have you been blogging for? you made blogging glance easy. The whole glance of your web site is magnificent, as well as the content material!

12:56 am July 11, 2011

rk10007 wrote :

I have been rendered a cripple thanks to running out of colchicine. Spent the week in agony, on crutches, unable to work, shop or take care of myself - all for want of a nickel pill. The FDA granted monopoly is nothing short of a tax, scam, sellout. I pay for the FDA and they sell me out to the pharma industry. What a bunch of pricks.

3:03 pm June 22, 2011

Ben wrote :

Hey FDA, thanks for bringing the cost of a 4-6 cent pill up to $5 a pill. It is nothing shy of complete ignorance on the FDA's part and it would not suprise me that there was insider infulence from URl Pharma to get "exclusive" rights to the drug, then raise the price 14,600%!!!!!!!!!!!! Yes you read that right.... 14,600%. Gee thanks FDA!

3:33 pm May 20, 2011

dwg wrote :

I take colchicine 4x daily and i'm 43 years old. Not only do I and my HMO have to absorb an increased cost, even with URLs assistance- but CVS Pharmacy tells me they don't have an adequate supply and I have to wait 2 days. I'm glad I called early.